This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for 1) the following design modifications to the current, legally marketed port-a-cath(r) ii: a smaller (25. 4mm. Based diameter, a 12. 7mm. Height, and a 8. 9mm. Septum diameter), lighter weight (5. 0 grams) portal with a titanium outlet tube; a filter change from a 60 micron stainless steel(ss) screen to a 20 micron sintered titanium filter; and a change to a titanium locking wing portion of the cath-shield catheter connector; and 2) the labeling revisions as delineated in the first amendment dated 6/23/98.
| Device | PORT-A-CATH(R) EPIDURAL IMPLANTABLE ACCESS SYST |
| Generic Name | Catheter, Percutaneous, Long Term, Intraspinal |
| Applicant | SMITHS MEDICAL ASD, INC. |
| Date Received | 1998-04-07 |
| Decision Date | 1998-10-20 |
| PMA | P900052 |
| Supplement | S005 |
| Product Code | LNY |
| Advisory Committee | General Hospital |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SMITHS MEDICAL ASD, INC. 1265 Grey Fox Road st. Paul, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P900052 | Original Filing | |
| S018 | 2013-04-22 | 30-day Notice |
| S017 | 2009-09-21 | Real-time Process |
| S016 | 2008-08-11 | Real-time Process |
| S015 | 2007-05-25 | 135 Review Track For 30-day Notice |
| S014 | 2006-12-08 | 135 Review Track For 30-day Notice |
| S013 | 2006-07-26 | 135 Review Track For 30-day Notice |
| S012 | 2002-10-30 | Real-time Process |
| S011 | 2002-09-04 | 30-day Notice |
| S010 | 2001-10-31 | Normal 180 Day Track |
| S009 | 2001-09-11 | 30-day Notice |
| S008 | 1999-09-07 | 30-day Notice |
| S007 | 1999-02-11 | Normal 180 Day Track |
| S006 | 1998-06-04 | Normal 180 Day Track |
| S005 | 1998-04-07 | Normal 180 Day Track |
| S004 | 1996-02-23 | Normal 180 Day Track |
| S003 | 1995-06-26 | Normal 180 Day Track |
| S002 | 1994-06-28 | Normal 180 Day Track |
| S001 |